Used to treat conditions including bipolar disorder and schizophrenia, Risperdal is an antipsychotic drug that has prompted hundreds of lawsuits as a result of its adverse side effects. The most profound side effect is abnormal breast growth in boys and adolescents, a condition known as gynecomastia. Plaintiffs have alleged that Johnson & Johnson neglected to properly warning physicians and consumers about the drug’s harmful side effects, and that Risperdal was not properly researched before being marketed. Gynecomastia can be a traumatic condition for pubescent boys, and parents should be aware of the potential risks posed by the administration of Risperdal.
Risperdal is medically considered an “atypical antipsychotic.” It alters the activity of dopamine and serotonin in the brain and is designed to treat schizophrenia in adults and bipolar disorder in children and adolescents. Autism symptoms in boys ages 6-16 that are alleviated by Risperdal include irritability, aggression, self-harm, and sudden mood changes.
Along with affecting dopamine and serotonin activity, Risperdal can also increase the production of prolactin. Prolactin is a hormone prominent in women that stimulates the growth of breast tissue. Excess prolactin can lead to tissue growth is called gynecomastia. The majority of lawsuits against Johnson & Johnson cited this side effect, along with breast tenderness and discharge. In 2006, research conducted in Switzerland showed that one out of 10 boys taking Risperdal developed gynecomastia. The same year, the FDA conducted a study comparing Risperdal with six other antipsychotic medications. Of these, Risperdal was responsible for 63 percent of gynecomastia cases in men and 82 percent in children and adolescents.
Additional serious side effects that are cause for immediate concern may include:
According to allegations, Johnson & Johnson’s failure to adequately research the side effects of Risperdal resulted in a lack of marketed warnings when the drug was released. To date, the pharmaceutical giant has settled over 130 claims involving gynecomastia in pubescent males. The legal claims against Johnson & Johnson are nowhere near close to an end.
In 2013, the federal government sought civil and criminal penalties from Johnson & Johnson after learning the company was marketing Risperdal as a treatment for agitation caused by dementia – a purpose never approved by the FDA. Johnson & Johnson ultimately agreed to pay the government $2.2 billion in one of the largest pharmaceutical settlements in U.S. history.
If you or a loved one has had a negative reaction to Risperdal or any other improperly-labeled medication, you may be eligible for compensation. At Berkowitz and Hanna LLC, we understand that the results of unsafe medications can be devastating, and we want to help you win the compensation you deserve. Contact Berkowitz and Hanna LLC today for a consultation, free of charge.